FDA approves semaglutide for type 2 diabetes

The FDA approved a new drug application for the GLP-1 receptor agonist semaglutide for the treatment of type 2 diabetes in adults, Novo Nordisk announced in a press release.

The once-weekly semaglutide injection (Ozempic), available in 0.5-mg and 1-mg formulations in a prefilled pen, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It can be taken at any time of day, with or without meals.

The approval of semaglutide follows results from a SUSTAIN clinical trial program. In people with type 2 diabetes, semaglutide showed reductions in HbA1c compared with placebo, sitagliptin and exenatide extended-release. As a secondary endpoint in the trials, treatment with semaglutide resulted in reductions in body weight.

The most common adverse reactions reported in at least 5% of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and constipation.

“The Ozempic approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk, said in the release. “We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly Ozempic to the type 2 diabetes community.”

The global phase 3a clinical trial program for semaglutide comprised eight clinical trials involving more than 8,000 adults with type 2 diabetes, including a 2-year cardiovascular outcomes trial that evaluated safety in adults with type 2 diabetes at high risk for CV events.

“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their HbA1c goals,” Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists, said in a statement. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their HbA1c goals.”

Novo Nordisk expects to launch semaglutide in the U.S. in the first quarter of 2018, with a goal of ensuring broad insurance coverage and patient access to the product. The drug will be priced at parity to current market-leading weekly GLP-1 receptor agonists, Novo Nordisk said in the release, and will be offered with a savings card program to reduce co-pays for eligible commercially insured patients.

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Additionally, as part of the access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.

In October, an FDA advisory panel voted 16 to 0, with one abstention, in favor of recommending approval for semaglutide, with the panel also expressing concern regarding a potential increase in the risk for complications related to diabetic retinopathy observed during the SUSTAIN-6 trial, in which retinopathy was a prespecified secondary outcome. However, most panel members agreed the issue could be addressed with wording on the drug’s label, which Novo Nordisk offered to do during its morning presentation.

Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.